Central Venous Catheter PlacementNCT05452590
Wire-in-needle vs. Traditional Technique for Ultrasound-guided Central Venous Catheter Placement
A study testing Ultrasound-guided wire-in-needle technique for central venous catheter placement in people with Central Venous Catheter Placement, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Central venous catheters (CVC) are commonly inserted in surgical or critically ill patients. However, CVC placement can cause severe complications. To reduce the incidence of complications and increase procedural safety and quality, ultrasound (US)-guided CVC insertion is recommended by various scientific societies… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Catheter Placement
- What is being tested?
- Ultrasound-guided wire-in-needle technique for central venous catheter placement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jul 2022to 25 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for elective cardiac surgery at the University Heart Center Hamburg-Eppendorf in whom CVC placement and sheath introducer central line placement in the internal jugular vein is indicated for clinical reasons unrelated to the study
- age > 18 years
- Written informed consent
Who cannot join
- longitudinal (long axis) view cannot be performed because of anatomical reasons (e.g., short neck).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wire-in-needle vs. Traditional Technique for Ultrasound-guided Central Venous Catheter Placement - a Randomized Controlled Trial (The WIN-Study)
Central venous catheters (CVC) are commonly inserted in surgical or critically ill patients. However, CVC placement can cause severe complications. To reduce the incidence of complications and increase procedural safety and quality, ultrasound (US)-guided CVC insertion is recommended by various scientific societies, including the American Society of Anesthesiologists.
During conventional US-guided CVC placement, the correct position of the needle tip in the venous vessel is confirmed by direct US visualization and aspiration of blood using a syringe connected to the needle. After blood aspiration, the operator must discontinue US-guidance to disconnect the syringe and the needle and to pass the guidewire through the needle (without direct US visualization). This step bears the risks of dislocating the needle tip and puncturing the posterior wall of the target vein or an adjacent artery.
Some authors thus propose an US-guided wire-in-needle technique - in which the guidewire is directly adapted to the needle (without a syringe) from the beginning of the procedure and the guidewire is advanced under direct US visualization. Whether the wire-in-needle technique decreases the procedure time, the number of needle passes, and complications compared to conventional US-guided CVC remains scarcely investigated. We thus propose a randomized controlled trial to investigate whether the US-guided wire-in-needle technique for CVC placement in the internal jugular vein (IJV) is faster and safer than the conventional US-guided technique in patients having cardiac surgery.
Read the detailed description
Patients scheduled for elective cardiac surgery receive a CVC and sheath introducer central line in the same internal jugular vein. Both catheters require the insertion of a guidewire into the vein to insert the catheter (seldinger technique). The anesthesiologist is going to place both guidewires before advancing the catheters over the guidewires.
The IJV will be examined before catheter placement to confirm that a long-axis view is possible. The right IJV will be chosen for CVC and sheath introducer central line placement. Patients will be then randomized to the US-guided wire-in-needle technique or the conventional US-guided technique just before catheter placement. Randomization will thus be concealed until the last practical moment. The patients will be randomized by a computer algorithm. Patients will be blinded to group allocation.
Anesthesiologists inserting the catheters will have at least 2-month experience in both US-guided wire-in-needle technique or the conventional US-guided technique. Patients will be equipped with basic anesthetic monitoring (electrocardiogram, pulse oximetry, upper-arm cuff oscillometry) and an arterial catheter. All patients will be intubated and mechanically ventilated during the procedure. The patient will be placed in a 15° Trendelenburg position. Catheter placement will be performed under sterile conditions with the US probe covered with a sterile cover.
US-guided wire-in-needle technique The guidewire will be connected to the needle. The IJV will be punctured in a long-axis in-plane approach. When the needle tip enters the IJV, the guidewire will be advanced through the needle into the IJV under continuous ultrasound visualization. The needle will then be removed. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view. Afterwards, the second guidewire will be placed in the same IJV approximately 1-2 centimeters distal to the fist guidewire using the same technique. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view again.
Traditional technique A syringe will be connected to the needle. The IJV will be punctured in a long-axis in-plane or short-axis out-of-plane approach (as preferred by the anesthesiologist). When the needle tip enters the IJV, blood is aspirated using the syringe. The operator will then discontinue US-guidance, disconnect the syringe and advance the guidewire through the needle into the IJV. The needle will then be removed. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view. Afterwards, the second guidewire will be placed in the same IJV approximately 1-2 centimeters distal to the fist guidewire using the same technique. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view again.
- Conditions
- Central Venous Catheter Placement
- Being tested
- Ultrasound-guided wire-in-needle technique for central venous catheter placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided wire-in-needle technique for central venous catheter placementProcedure or surgery
The guidewire will be connected to the needle. The IJV will be punctured in a long-axis in-plane approach. When the needle tip enters the IJV, the guidewire will be advanced through the needle into the IJV under continuous ultrasound visualization. The needle will then be removed. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view. Afterwards, the second guidewire will be placed in the same IJV approximately 1-2 centimeters distal to the fist guidewire using the same technique. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view again.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided wire-in-needle technique | Experimental | The guidewire will be connected to the needle. The IJV will be punctured in a long-axis in-plane approach. When the needle tip enters the IJV, the guidewire will be advanced through the needle into the IJV under continuous ultrasound visualization. The needle will then be removed. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view. Afterwards, the second guidewire will be placed in the same IJV approximately 1-2 centimeters distal to the fist guidewire using the same technique. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view again. Receives: Procedure: Ultrasound-guided wire-in-needle technique for central venous catheter placement |
| Traditional technique | No intervention | A syringe will be connected to the needle. The IJV will be punctured in a long-axis in-plane or short-axis out-of-plane approach (as preferred by the anesthesiologist). When the needle tip enters the IJV, blood is aspirated using the syringe. The operator will then discontinue US-guidance, disconnect the syringe and advance the guidewire through the needle into the IJV. The needle will then be removed. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view. Afterwards, the second guidewire will be placed in the same IJV approximately 1-2 centimeters distal to the fist guidewire using the same technique. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view again. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time between skin puncture and removal of the needle during placement of the first guidewire.
Time between skin puncture and removal of the needle during placement of the first guidewire in seconds.
Measured: From the beginning of central venous catheter placement till the end of central venous catheter placement.
Secondary outcomes (6)
Complications
arterial puncture
Measured: From the beginning of central venous catheter placement till the end of central venous catheter placement.
Complications
posterior wall puncture/hematoma
Measured: From the beginning of central venous catheter placement till the end of central venous catheter placement.
Complications
cervical hematoma
Measured: From the beginning of central venous catheter placement till the end of central venous catheter placement.
Number of needle passes
Number of needle passes required to place the wire in the vessel
Measured: From the beginning of central venous catheter placement till the end of central venous catheter placement.
Number of skin punctures
Number of skin punctures required to place the wire in the vessel
Measured: From the beginning of central venous catheter placement till the end of central venous catheter placement.
First-pass success rate
First-pass success rate for placing the wire in the vessel
Measured: From the beginning of central venous catheter placement till the end of central venous catheter placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start6 Jul 2022
- Primary completion13 Jun 2023
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Venous Catheter PlacementStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristen Thomsen, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452590
- Sponsor's protocol ID
- 2022-100852-BO-ff
- Status last verified
- Nov 2023
- First submitted
- 6 Jul 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thomsen KK, Stekovic J, Koster F, Bergholz A, Kouz K, Flick M, Sessler DI, Zollner C, Saugel B, Schulte-Uentrop L. Wire-in-needle versus conventional syringe-on-needle technique for ultrasound-guided central venous catheter insertion in the internal jugular vein: the WIN randomized trial. J Clin Monit Comput. 2025 Oct;39(5):805-811. doi: 10.1007/s10877-024-01232-4. Epub 2024 Oct 14.
PubMed 39400666
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wire-in-needle vs. Traditional Technique for Ultrasound-guided Central Venous Catheter Placement - a Randomized Controlled Trial (The WIN-Study)
- ClinicalTrials.gov ID
- NCT05452590
- Acronym / sponsor ID
- 2022-100852-BO-ff
- Conditions
- Central Venous Catheter Placement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Central venous catheters (CVC) are commonly inserted in surgical or critically ill patients. However, CVC placement can cause severe complications. To reduce the incidence of complications and increase procedural safety and quality, ultrasound (US)-guided CVC insertion is recommended by various scientific societies, including the American Society of Anesthesiologists.
During conventional US-guided CVC placement, the correct position of the needle tip in the venous vessel is confirmed by direct US visualization and aspiration of blood using a syringe connected to the needle. After blood aspiration, the operator must discontinue US-guidance to disconnect the syringe and the needle and to pass the guidewire through the needle (without direct US visualization). This step bears the risks of dislocating the needle tip and puncturing the posterior wall of the target vein or an adjacent artery.
Some authors thus propose an US-guided wire-in-needle technique - in which the guidewire is directly adapted to the needle (without a syringe) from the beginning of the procedure and the guidewire is advanced under direct US visualization. Whether the wire-in-needle technique decreases the procedure time, the number of needle passes, and complications compared to conventional US-guided CVC remains scarcely investigated. We thus propose a randomized controlled trial to investigate whether the US-guided wire-in-needle technique for CVC placement in the internal jugular vein (IJV) is faster and safer than the conventional US-guided technique in patients having cardiac surgery.
Detailed description
Patients scheduled for elective cardiac surgery receive a CVC and sheath introducer central line in the same internal jugular vein. Both catheters require the insertion of a guidewire into the vein to insert the catheter (seldinger technique). The anesthesiologist is going to place both guidewires before advancing the catheters over the guidewires.
The IJV will be examined before catheter placement to confirm that a long-axis view is possible. The right IJV will be chosen for CVC and sheath introducer central line placement. Patients will be then randomized to the US-guided wire-in-needle technique or the conventional US-guided technique just before catheter placement. Randomization will thus be concealed until the last practical moment. The patients will be randomized by a computer algorithm. Patients will be blinded to group allocation.
Anesthesiologists inserting the catheters will have at least 2-month experience in both US-guided wire-in-needle technique or the conventional US-guided technique. Patients will be equipped with basic anesthetic monitoring (electrocardiogram, pulse oximetry, upper-arm cuff oscillometry) and an arterial catheter. All patients will be intubated and mechanically ventilated during the procedure. The patient will be placed in a 15° Trendelenburg position. Catheter placement will be performed under sterile conditions with the US probe covered with a sterile cover.
US-guided wire-in-needle technique The guidewire will be connected to the needle. The IJV will be punctured in a long-axis in-plane approach. When the needle tip enters the IJV, the guidewire will be advanced through the needle into the IJV under continuous ultrasound visualization. The needle will then be removed. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view. Afterwards, the second guidewire will be placed in the same IJV approximately 1-2 centimeters distal to the fist guidewire using the same technique. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view again.
Traditional technique A syringe will be connected to the needle. The IJV will be punctured in a long-axis in-plane or short-axis out-of-plane approach (as preferred by the anesthesiologist). When the needle tip enters the IJV, blood is aspirated using the syringe. The operator will then discontinue US-guidance, disconnect the syringe and advance the guidewire through the needle into the IJV. The needle will then be removed. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view. Afterwards, the second guidewire will be placed in the same IJV approximately 1-2 centimeters distal to the fist guidewire using the same technique. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view again.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided wire-in-needle technique | Experimental | Procedure: Ultrasound-guided wire-in-needle technique for central venous catheter placementThe guidewire will be connected to the needle. The IJV will be punctured in a long-axis in-plane approach. When the needle tip enters the IJV, the guidewire will be advanced through the needle into the IJV under continuous ultrasound visualization. The needle will then be removed. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view. Afterwards, the second guidewire will be placed in the same IJV approximately 1-2 centimeters distal to the fist guidewire using the same technique. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view again. |
| Traditional technique | No intervention | –A syringe will be connected to the needle. The IJV will be punctured in a long-axis in-plane or short-axis out-of-plane approach (as preferred by the anesthesiologist). When the needle tip enters the IJV, blood is aspirated using the syringe. The operator will then discontinue US-guidance, disconnect the syringe and advance the guidewire through the needle into the IJV. The needle will then be removed. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view. Afterwards, the second guidewire will be placed in the same IJV approximately 1-2 centimeters distal to the fist guidewire using the same technique. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view again. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients scheduled for elective cardiac surgery at the University Heart Center Hamburg-Eppendorf in whom CVC placement and sheath introducer central line placement in the internal jugular vein is indicated for clinical reasons unrelated to the study
- age > 18 years
- Written informed consent
Key exclusion criteria (1 listed)
- longitudinal (long axis) view cannot be performed because of anatomical reasons (e.g., short neck).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided wire-in-needle technique for central venous catheter placementThe guidewire will be connected to the needle. The IJV will be punctured in a long-axis in-plane approach. When the needle tip enters the IJV, the guidewire will be advanced through the needle into the IJV under continuous ultrasound visualization. The needle will then be removed. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view. Afterwards, the second guidewire will be placed in the same IJV approximately 1-2 centimeters distal to the fist guidewire using the same technique. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view again. | Procedure or surgery | Ultrasound-guided wire-in-needle technique |
Primary outcome
Time between skin puncture and removal of the needle during placement of the first guidewire.
Time frame: From the beginning of central venous catheter placement till the end of central venous catheter placement.
Time between skin puncture and removal of the needle during placement of the first guidewire in seconds.
6 secondary outcomes
Complications
Time frame: From the beginning of central venous catheter placement till the end of central venous catheter placement.
Complications
Time frame: From the beginning of central venous catheter placement till the end of central venous catheter placement.
Complications
Time frame: From the beginning of central venous catheter placement till the end of central venous catheter placement.
Number of needle passes
Time frame: From the beginning of central venous catheter placement till the end of central venous catheter placement.
Number of skin punctures
Time frame: From the beginning of central venous catheter placement till the end of central venous catheter placement.
First-pass success rate
Time frame: From the beginning of central venous catheter placement till the end of central venous catheter placement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 39400666Thomsen KK, Stekovic J, Koster F, Bergholz A, Kouz K, Flick M, Sessler DI, Zollner C, Saugel B, Schulte-Uentrop L. Wire-in-needle versus conventional syringe-on-needle technique for ultrasound-guided central venous catheter insertion in the internal jugular vein: the WIN randomized trial. J Clin Monit Comput. 2025 Oct;39(5):805-811. doi: 10.1007/s10877-024-01232-4. Epub 2024 Oct 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided wire-in-needle technique for central venous catheter placement in people with Central Venous Catheter Placement, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time between skin puncture and removal of the needle during placement of the first guidewire. (time frame: From the beginning of central venous catheter placement till the end of central venous catheter placement.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05452590, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.